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Non-invasive Brain Stimulation

Brain Stimulation for Speech Disorders

Phase < 1
Waitlist Available
Led By John Hart, MD
Research Sponsored by The University of Texas at Dallas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 to 85 years of age
A formal diagnosis of primary progressive aphasia (nonfluent/agrammatic, semantic, logopenic variants or mixed) and/or progressive apraxia of speech
Must not have
A significant history of arrhythmia or epileptic seizures.
Currently receiving speech-language intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment change from baseline to immediate post, and 8 weeks post treatment completion.
Awards & highlights

Summary

This trial is testing whether electrical stimulation of the brain can improve speech and language difficulties in patients with primary progressive aphasia or progressive apraxia of speech.

Who is the study for?
This trial is for adults aged 18-85 with primary progressive aphasia or apraxia of speech, who can consent to participate. It's not suitable for those currently in speech therapy, with implanted devices like pacemakers, skull defects, non-native English speakers, a history of seizures or arrhythmias, or if pregnant.
What is being tested?
The study tests if transcranial direct current stimulation (tDCS) on the brain area linked to memory can help improve speech and language issues in patients with aphasia and apraxia of speech. Speech/language functions are primarily measured alongside other cognitive abilities and EEG readings.
What are the potential side effects?
Potential side effects from tDCS may include mild discomfort at the stimulation site, itching or tingling during application, headache, fatigue after treatment sessions. Serious side effects are rare but could involve seizure risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 85 years old.
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I have been diagnosed with a specific type of speech disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of irregular heartbeats or seizures.
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I am currently getting help from a speech therapist.
Select...
I have a defect in my skull.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment change from baseline to immediate post, and 8 weeks post treatment completion.
This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment change from baseline to immediate post, and 8 weeks post treatment completion. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Category Fluency
Spontaneous speech (content and fluency) of the Western Aphasia Battery-Revised
The Apraxia battery for Adults - 2 (ABA - 2)
+2 more
Secondary study objectives
The Digit Span Forward & Backward
The Digit Symbol Substitution Test
The Hopkins Verbal Learning Test-Revised
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Active tDCS treatmentExperimental Treatment1 Intervention
This pilot study has one treatment arm with open-label treatment and will examine improvement of speech output, verbal fluency, and other cognitive deficits associated with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS), by utilizing 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to pre-supplementary motor area for 20 minutes over 10 sessions. There will be baseline testing, and follow up testing immediately after and 8 weeks after completion of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial direct current stimulation
2012
Completed Phase 3
~650

Find a Location

Who is running the clinical trial?

The University of Texas at DallasLead Sponsor
62 Previous Clinical Trials
106,629 Total Patients Enrolled
John Hart, MDPrincipal InvestigatorUniversity of Texas at Dallas
2 Previous Clinical Trials
110 Total Patients Enrolled

Media Library

Transcranial direct current stimulation (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05368350 — Phase < 1
Primary Progressive Aphasia Research Study Groups: Active tDCS treatment
Primary Progressive Aphasia Clinical Trial 2023: Transcranial direct current stimulation Highlights & Side Effects. Trial Name: NCT05368350 — Phase < 1
Transcranial direct current stimulation (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05368350 — Phase < 1
~1 spots leftby Dec 2024
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